Degenerative arthritis of knee joint
Conditions
Interventions
Low dose exosome treatment group:ARTZ(Sodium Hyaluronate Injection) 2.5ml (25mg)+5 × 10 ^ 9 particles of extracellular vesicles, injected into the knee joint cavity
Control group:ARTZ(Sodium Hyaluronate Injection) 2.5ml (25mg), injected into the knee joint cavity
High dose exosome treatment group:ARTZ(Sodium Hyaluronate Injection) 2.5ml (25mg)+1 × 10 ^ 10 particles of extracellular vesicles, injected into the knee joint cavity
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen University Liver Disease Hospital)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participants who are able to understand and complete the research questionnaire, willing to sign informed consent forms, and comply with the requirements of the research protocol. 2. Age range: 40-70 years old, male or female not limited. 3. 18.5= 40mm). 7. The affected joint is a unilateral knee joint. 8. When screening, if the subject is taking nonsteroidal anti-inflammatory drugs (NSAIDs), the dose should be stable for at least 2 weeks before the first dose. 9. Hypertensive patients who have not developed any new cardiovascular or cerebrovascular diseases within 6 months and have achieved stable drug control can be selected.
Exclusion criteria
Exclusion criteria: 1. Secondary osteoarthritis, such as purulent arthritis, inflammatory joint disease, gouty arthritis, traumatic arthritis, etc. 2. Accompanied by other rheumatic diseases such as systemic lupus erythematosus, inflammatory bowel disease, Felty syndrome, scleroderma, etc. 3. Individuals who have received intra-articular drug injections within the past 3 months. 4. Those who have undergone arthroscopy or total joint replacement surgery within 6 months. 5. Individuals who use anticoagulants and antiplatelet agents. 6. Individuals with tumor diseases or a history of tumor diseases. 7. There are serious diseases under control, such as diabetes, hypertension, kidney disease, liver disease or serious heart disease, and the researcher judges that they are not suitable to join this study. 8. Patients with positive AIDS, hepatitis B and syphilis (excluding those with positive test results). 9. Screening individuals who have participated in clinical trials of other drugs within the previous 3 months. 10. Pregnant, breastfeeding, and pre pregnancy women. 11. Those who have used stem cell therapy within six months. 12. Individuals with mental disorders or uncontrolled or poorly controlled mental illnesses. 13. Individuals with a history of alcohol and drug abuse, as well as those with allergies or a history of allergies. 14. The researchers believe that patients who are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indicators;WOMAC Knee Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood laboratory test indicators;Global Perceived Effect;12-Item Short Form Health Survey;Imaging data;Levels of inflammatory factors in synovial fluid;Visual Analogue Scale; | — |
Countries
China
Contacts
Public ContactWang Kun
The Third Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen University Liver Disease Hospital)
Outcome results
None listed